Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects

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Wyeth

Status and phase

Completed
Phase 3

Conditions

Hemophilia B

Treatments

Biological: Benefix

Study type

Interventional

Funder types

Industry

Identifiers

NCT00866606
B1821004
3090A1-3305

Details and patient eligibility

About

This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in Chinese hemophilia B subjects.

Enrollment

35 patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia B (FIX activity: more than 5%, 1-5%, or less than 1%, respectively)
  • Subjects with previous exposure to FIX replacement therapy
  • If HIV positive, documented CD4 count more than 200/µL within 6 months of study entry

Exclusion criteria

  • Diagnosed with any bleeding disorder in addition to hemophilia B
  • Current FIX inhibitor or history of FIX inhibitor (defined as >ULN of the reporting laboratory)
  • Subject has no history of exposure to FIX products (previously untreated patient [PUP])
  • Subject is currently utilizing primary FIX prophylaxis
  • Subjects anticipating elective surgery that may be planned to occur in the 6 months following study entry
  • Treated with immunomodulatory therapy within 30 days prior to study entry or planned use for the duration of their study participation
  • Participated in another investigational drug or device study within 30 days prior to study entry or planned participation for the duration of their study participation
  • Subjects with a known hypersensitivity to hamster protein
  • Significant hepatic or renal impairment (ALT and AST >5 x ULN, bilirubin >2 mg/dL or serum creatinine >1.25 x ULN)
  • Prothrombin Time >1.5 x ULN
  • Platelet count <80,000/µL
  • Pregnant or breastfeeding women
  • Unwilling or unable to follow the terms of the protocol
  • Any condition which may compromise the subject's ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation, in the opinion of the Investigator or Sponsor

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

Benefix
Experimental group
Description:
Subjects received on-demand treatments with BeneFIX over a 6-month (calendar day) period.
Treatment:
Biological: Benefix

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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